Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05988567
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Testing of Melon Oil Olive Pressed Candy Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The change of self-assessment skin and hair condition', 'timeFrame': 'Change from Baseline skin and hair condition at 12 weeks', 'description': 'A self-assessment questionnaire was collected to evaluate skin and hair condition'}], 'primaryOutcomes': [{'measure': 'The change of skin wrinkles', 'timeFrame': 'Change from Baseline skin wrinkles at 12 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units'}, {'measure': 'The change of skin texture', 'timeFrame': 'Change from Baseline skin texture at 12 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units'}, {'measure': 'The change of skin melanin index', 'timeFrame': 'Change from Baseline skin melanin index at 12 weeks', 'description': 'Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units'}, {'measure': 'The change of skin erythema index', 'timeFrame': 'Change from Baseline skin erythema index at 12 weeks', 'description': 'Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units'}, {'measure': 'The change of skin L* value', 'timeFrame': 'Change from Baseline L* value at 12 weeks', 'description': 'Chroma Meter MM500 was utilized to measure skin L\\* value. Units: arbitrary units'}, {'measure': 'The change of skin b* value', 'timeFrame': 'Change from Baseline b* value at 12 weeks', 'description': 'Chroma Meter MM500 was utilized to measure skin b\\* value. Units: arbitrary units'}, {'measure': 'The change of skin ITA° value', 'timeFrame': 'Change from Baseline ITA° value at 12 weeks', 'description': 'Chroma Meter MM500 was utilized to measure skin ITA° value. Units: arbitrary units'}, {'measure': 'The change of skin spots', 'timeFrame': 'Change from Baseline skin spots at 12 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units'}, {'measure': 'The change of skin UV spots', 'timeFrame': 'Change from Baseline skin UV spots at 12 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units'}, {'measure': 'The change of skin brown spots', 'timeFrame': 'Change from Baseline skin brown spots at 12 weeks', 'description': 'VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units'}], 'secondaryOutcomes': [{'measure': 'The change of TEAC of blood', 'timeFrame': 'Change from Baseline TEAC at 12 weeks', 'description': 'Venous blood was sampled to measure TEAC'}, {'measure': 'The change of SOD of blood', 'timeFrame': 'Change from Baseline SOD at 12 weeks', 'description': 'Venous blood was sampled to measure SOD'}, {'measure': 'The change of GSH-Px of blood', 'timeFrame': 'Change from Baseline GSH-Px at 12 weeks', 'description': 'Venous blood was sampled to measure GSH-Px'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Condition']}, 'referencesModule': {'references': [{'pmid': '39927597', 'type': 'DERIVED', 'citation': 'He Y, Bu Y, Chiang CF, Lin YH, Liang CH, Chan LP, Sun J. Multi-Plant Concentrated Powder Improved Skin Whitening: A Double-Blinded, Randomized, and Placebo-Controlled Clinical Study. J Cosmet Dermatol. 2025 Feb;24(2):e70011. doi: 10.1111/jocd.70011.'}]}, 'descriptionModule': {'briefSummary': 'To assess melon and oil olive pressed candy on skin condition improvement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged above 18 years old\n* ITA° value 20°-41°\n\nExclusion Criteria:\n\n* Involuntary subjects.\n* Subjects who have a history of skin diseases such as psoriasis, eczema, atopic dermatitis, severe acne; or suffer from other chronic systemic disease.\n* Those with known cosmetic, drug or food allergies.\n* Female who is pregnant or nursing or planning to become pregnant during the course of the study.\n* Subjects who have taken oral or topical corticosteroids and other anti-inflammatory drugs in the past 1 month.\n* Use of any products or drugs that affect skin color such as fruit acid, salicylic acid (such as Hydroquinone preparations) in the past 2 months.\n* In the past 3 months, the test site has used retinoic acid preparations or undergone chemical peeling, laser, pulse light and other medical aesthetic therapists\n* Subjects who can not avoid long-term sun exposure'}, 'identificationModule': {'nctId': 'NCT05988567', 'briefTitle': 'Efficacy Testing of Melon Oil Olive Pressed Candy Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Efficacy Testing of Melon Oil Olive Pressed Candy Products', 'orgStudyIdInfo': {'id': '23-049-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo candy', 'interventionNames': ['Dietary Supplement: Placebo candy']}, {'type': 'EXPERIMENTAL', 'label': 'melon and oil olive pressed candy', 'interventionNames': ['Dietary Supplement: melon and oil olive pressed candy']}], 'interventions': [{'name': 'Placebo candy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 2 tablets per day', 'armGroupLabels': ['Placebo candy']}, {'name': 'melon and oil olive pressed candy', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Melon, oil olive and pomegranate blend pressed candy'], 'description': 'consume 2 tablets per day', 'armGroupLabels': ['melon and oil olive pressed candy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chia Nan University of Pharmacy & Science', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Chia-Hua Liang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chia Nan University of Pharmacy ＆ Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}